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Head-to-Head Comparison of Two SARS-CoV-2 Serology Assays.
J Appl Lab Med. 2020 11 01; 5(6):1351-1357.JA

Abstract

BACKGROUND

While molecular techniques remain the gold standard for diagnosis of acute SARS-CoV-2 infection, serological tests have the unique potential to ascertain how much of the population has been exposed to the COVID-19 pathogen. There have been limited published studies to date documenting the performance of SARS-CoV-2 antibody assays.

METHODS

We compared the DiaSorin Liaison SARS-CoV-2 S1/S2 IgG and Roche Diagnostics Elecsys Anti-SARS-CoV-2 assays using 228 samples spanning patients with positive PCR for SARS-CoV-2, patients with compatible symptoms but negative PCR, pre-COVID specimens, and potential cross-reactives.

RESULTS

Both assays detected antibodies in 18/19 samples collected at least one week after a positive PCR result. Neither method consistently detected antibodies in specimens collected within one week of a positive PCR result (sensitivity < 50%), but antibodies were detected by only Roche in four samples in this time frame. Using 139 pre-COVID and 35 PCR-negative samples, the Roche and DiaSorin assays demonstrated specificities of 100.0% and 98.9%, respectively. Neither assay demonstrated cross-reactivity from other coronaviruses (229E, HKU1, NL63, OC43), respiratory pathogens (adenovirus, metapneumovirus, rhinovirus/enterovirus), or antibodies to other viruses (HIV, EBV, CMV, HBV, HCV, HAV).

DISCUSSION

Overall, the qualitative interpretations afforded by the Roche and DiaSorin assays agreed for 97% of samples evaluated. Minor discrepancies in sensitivity and specificity were observed between methods, with the differences in specificity more clinically significant for our low-prevalence population. For the DiaSorin assay, all disagreements with the Roche assay occurred in samples with quantitative signals near the cut-off determining positivity.

Authors+Show Affiliations

Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, IA.Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, IA.Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, IA.Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, IA.Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, IA.

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

32717056

Citation

Merrill, Anna E., et al. "Head-to-Head Comparison of Two SARS-CoV-2 Serology Assays." The Journal of Applied Laboratory Medicine, vol. 5, no. 6, 2020, pp. 1351-1357.
Merrill AE, Jackson JB, Ehlers A, et al. Head-to-Head Comparison of Two SARS-CoV-2 Serology Assays. J Appl Lab Med. 2020;5(6):1351-1357.
Merrill, A. E., Jackson, J. B., Ehlers, A., Voss, D., & Krasowski, M. D. (2020). Head-to-Head Comparison of Two SARS-CoV-2 Serology Assays. The Journal of Applied Laboratory Medicine, 5(6), 1351-1357. https://doi.org/10.1093/jalm/jfaa125
Merrill AE, et al. Head-to-Head Comparison of Two SARS-CoV-2 Serology Assays. J Appl Lab Med. 2020 11 1;5(6):1351-1357. PubMed PMID: 32717056.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Head-to-Head Comparison of Two SARS-CoV-2 Serology Assays. AU - Merrill,Anna E, AU - Jackson,J Brooks, AU - Ehlers,Alexandra, AU - Voss,Dena, AU - Krasowski,Matthew D, PY - 2020/05/30/received PY - 2020/07/06/accepted PY - 2020/7/28/pubmed PY - 2020/12/2/medline PY - 2020/7/28/entrez KW - COVID-19 KW - SARS-CoV-2 KW - immunoassay KW - serology SP - 1351 EP - 1357 JF - The journal of applied laboratory medicine JO - J Appl Lab Med VL - 5 IS - 6 N2 - BACKGROUND: While molecular techniques remain the gold standard for diagnosis of acute SARS-CoV-2 infection, serological tests have the unique potential to ascertain how much of the population has been exposed to the COVID-19 pathogen. There have been limited published studies to date documenting the performance of SARS-CoV-2 antibody assays. METHODS: We compared the DiaSorin Liaison SARS-CoV-2 S1/S2 IgG and Roche Diagnostics Elecsys Anti-SARS-CoV-2 assays using 228 samples spanning patients with positive PCR for SARS-CoV-2, patients with compatible symptoms but negative PCR, pre-COVID specimens, and potential cross-reactives. RESULTS: Both assays detected antibodies in 18/19 samples collected at least one week after a positive PCR result. Neither method consistently detected antibodies in specimens collected within one week of a positive PCR result (sensitivity < 50%), but antibodies were detected by only Roche in four samples in this time frame. Using 139 pre-COVID and 35 PCR-negative samples, the Roche and DiaSorin assays demonstrated specificities of 100.0% and 98.9%, respectively. Neither assay demonstrated cross-reactivity from other coronaviruses (229E, HKU1, NL63, OC43), respiratory pathogens (adenovirus, metapneumovirus, rhinovirus/enterovirus), or antibodies to other viruses (HIV, EBV, CMV, HBV, HCV, HAV). DISCUSSION: Overall, the qualitative interpretations afforded by the Roche and DiaSorin assays agreed for 97% of samples evaluated. Minor discrepancies in sensitivity and specificity were observed between methods, with the differences in specificity more clinically significant for our low-prevalence population. For the DiaSorin assay, all disagreements with the Roche assay occurred in samples with quantitative signals near the cut-off determining positivity. SN - 2576-9456 UR - https://www.unboundmedicine.com/medline/citation/32717056/Head_to_Head_Comparison_of_Two_SARS_CoV_2_Serology_Assays_ L2 - http://jalm.aaccjnls.org/cgi/pmidlookup?view=long&amp;pmid=32717056 DB - PRIME DP - Unbound Medicine ER -